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CIRCULAR No

CIRCULAR No. 8-BYT/TT ON THE 2nd OF MAY, 1994 GUIDING THE IMPLEMENTATION OF THE ORDINANCE ON PRIVATE MEDICAL AND PHARMACEUTICAL PRACTICE AND DECREE No. 6-CP ON THE 29th OF JANUARY 1994 OF THE GOVERNMENT CONCRETIZING A NUMBER OF ARTICLES OF THIS ORDINANCE IN THE AREA OF PRIVATE PRACTICE OF TRADITIONAL NATIONAL MEDICINE AND PHARMACY

To guide the private establishments engaged in traditional national medicine and pharmacy practice to operate according to law and to ensure safety for, the life and property of the people;

Pursuant to Chapter V of the Law on the Protection of the People's Health and the Rules for the practice of medical examination and treatment by traditional national medicine;

Pursuant to the Ordinance on Private Medical and Pharmaceutical Practice on the 30th of September 1993 and the Government Decree No. 6-CP on the 29th of January 1994 detailing a number of articles in the Ordinance;

The Ministry of Public Health hereby provides additional guidance on the criteria, conditions, procedures and competence in the issuing of certificates of qualifications for opening private establishments for the practice of traditional national medicine and pharmacy.

I. GENERAL PROVISIONS

1. Any Vietnamese citizen who meets the criteria and conditions stipulated in the Ordinance on Private Medical and Pharmaceutical Practice issued by the Standing Committee of the National Assembly and this guiding Circular of the Ministry of Public Health, is entitled to engage in one of the forms of private practice of traditional national medicine and pharmacy listed at Points 3 and 4 of this Circular.

Each person is allowed to carry out his practice at only one place as permitted by the competent medical office in the locality where the establishment is located. Any change of the location must have the consent of the competent services in the places where he is operating and where he shall move to.

2. Each establishment for private practice of traditional national medicine and pharmacy shall be registered for business by only one individual who is responsible before law for all the activities of the establishment.

3. Private practice of traditional national medicine and pharmacy comprises:

a/ The private clinic for traditional national medicine which is an in-patient and out-patient establishment for examination and treatment by traditional national methods (with or without medication) and by traditional national medicine with modern medicine. A private traditional national medicine hospital shall be set up and registered for business under the Law on Private Businesses or the Corporate Law.

b/ The private traditional national medicine establishments which register for business under Decree No.66-HDBT on the 2nd of March 1992 of the Council of Ministers concerning individual or group businesses having a capital lower than the prescribed capital stipulated at Decree No.221-HDBT on the 23rd of July 1991. These include:

- The traditional national medicine consulting and treatment room. This is a consulting and treatment room run by a group of national medicine practitioners registered for business operation in the name of a representative who is responsible before law. It may also be run by only one national medicine practitioner who registers on his own behalf.

- The convalescence and functional rehabilitation establishment of traditional national medicine. This is a place for patients to come for daily exercise by methods of traditional national medicine under the guidance of technicians or practitioners of national medicine.

- Therapeutical service establishments using acupuncture, massage, point pressure and fumigation conducted by national medicine technicians on the prescriptions of national medicine practitioners.

4. Private traditional national medicine dispensaries shall register their businesses according to Decree No. 66-HDBT on the 2nd of March 1992 issued by the Council of Ministers concerning business individuals or groups having a capital lower than the prescribed capital stipulated in Decree No.221-HDBT on the 23rd of July 1991. They comprise:

- Raw medicine dispensary: dealing in raw pharmaceutical materials of traditional national medicine.

- Processed medicine dispensary, preparing and dealing in processed pharmaceutical materials by traditional national medicine method.

- Establishments which produce and sell drugs in stacking patches, liquid, balls and powder by traditional national medicine method.

- Establishments which produce and sell family-transmitted medicine dealing exclusively in drugs handed down within the family.

- The agent distributor of traditional national medicine is the dispensary of products of the establishments producing traditional national medicine.

5. The applicant for opening a private establishment for traditional national medicine practice shall pay a fee as jointly stipulated by the Ministry of Finance and the Ministry of Public Health.

6. All advertisements on medical examinations and treatment and on drugs of the traditional national medicine must be approved and permitted by the Health Service.

II. CRITERIA AND CONDITIONS FOR OPENING AND AREAS OF OPERATION

OF PRIVATE TRADITIONAL NATIONAL MEDICINE AND PHARMACY

A. On traditional national medicine:

1. Criteria and conditions for opening and areas of operation of a traditional national medicine clinic:

1.1. The applicant to set up a private traditional national medicine clinic must be, in terms of professional qualification, a traditional national medicine doctor or a person recognized by the Ministry of Public Health or the Health Service as a general or specialized practitioner as stipulated in Circular No.11-BYT/TT on the 23rd of April 1991 of the Ministry of Public Health on the implementation of the Rules on medical examinations and treatment by traditional national medicine issued along with Decree No.23-HDBT on the 24th of January, 1991 of the Council of Ministers. He/she must have practiced at least for five years at lawful establishments for traditional national medicine.

The persons, who are working in State offices or other persons defined at Article 2 of the Regulation of the Council of Ministers detailing a number of articles in the Law in Private Businesses promulgated along with Decree No.221-HDBT on the 23rd of July 1991 by the Council of Ministers, are not entitled to set up in their names or join in the founding of a private traditional national medicine clinic.

- On the clinic staff: the clinic must have the necessary staff and personnel to care for patients. It must have the proper ratio of physicians (national medicine doctors, intermediate-level physicians and practitioners) to the total personnel in order to ensure the quality of medical examinations and treatment. The clinic may organize the following sections or departments:

+ Department for out-patient examinations and treatment.

+ Department for in-patient treatment.

+ A pharmacy section.

+ A department for financial, administrative and material management.

(Depending on the size of the clinic, these departments or sections must be so organized as to ensure the effective operation of the clinic).

- The site and space of the clinic must be large enough to ensure sanitary conditions for patients. Measures must be taken to ensure environmental sanitation.

- Equipment: The clinic must have the appropriate technical equipment for laboratory tests and diagnosis, for medical treatment and production and preparation of medicine.

Housing space: each department or section must have a separate working place to ensure the needs and specific character of the work.

- The clinic must have the necessary supply of clean water: well water or running water.

- The clinic must have the necessary toilets and bath rooms for patients and personnel.

- The clinic must have the necessary fire equipment.

1.2 Areas of operation: the clinic is entitled to conduct medical examinations, and treatment, convalescence and functional rehabilitation for its in-patients and out-patients by methods of traditional national medicine or in combination with modern medicine.

The pharmaceutical section or department is entitled to prepare traditional national medicine for in-patients and out-patients of the clinic.

2. Criteria, conditions and area of operation of a traditional national medicine consulting and treatment room of the group of national medicine physicians.

2.1. Criteria and conditions for opening a consulting and treatment room:

- The applicant for opening a consulting and treatment room must be, in terms of professional qualification, a doctor of national medicine or a person recognized by the Ministry of Public Health or the Health Service as a medicine practitioner (general or specialized) with at least five years of practice at a lawful establishment for traditional national medicine.

- A room for traditional national medicine diagnosis and treatment run by group of national medicine practitioners may comprise three sections:

+ A medical section (medical diagnosis and treatment).

+ A pharmaceutical section (preparation of drugs)

+ A financial and accounting section.

- The establishment for medical diagnosis and treatment must be large enough for operation, must be airy and sufficiently lighted and meet the sanitary conditions, must have a place for the waiting patients, a place for the practice of method of treatment such as acupuncture, massage and point pressure (if any), a place for selling medicine and a toilet room.

- Equipment: it must have enough furniture, compartmentalized drug cabinet, instruments for preparing and weighing medicine, means to preserve medicine (store house, shelves, drying oven...)

2.2. Area of operation:

- Giving medical examinations and treatment to outpatients by medication or non-medication methods of traditional national medicine allowed by the Ministry of Public Health. It is forbidden to accept patients with surgical prescriptions or emergency cases of child delivery.

- Preparing drugs and weighing them for direct sales to patients.

3. Criteria and conditions for opening an area of operation of a room for traditional national medicine diagnosis and treatment run by a traditional national medicine practitioner.

3.1 Criteria and conditions for opening and establishment:

- The applicant must be, in terms of professional qualification, a traditional national medicine doctor or physician, or a person recognized by the Ministry of Public Health or the health service as a practitioner with at least two years of practice at lawful establishments for traditional national medicine.

If he/she is a public servant still working in a State office, he/she can only apply for the practice of medical examinations and treatment outside office hours.

- The housing facilities must ensure the sanitary conditions and meet the demand for professional activities already licensed.

3.2 Area of operation:

- A general doctor, physician or practitioner of national medicine is entitled to feel the pulse, write prescriptions, prepare medicine and give medication and treat diseases by non-medication methods of traditional national medicine already approved by the Ministry of Public Health. A specialized practitioner is entitled to feel the pulse, write prescriptions, prepare medicine, give medication methods of traditional national medicine already approved by the Ministry of Public Health in the area of his/her speciality.

- A practitioner who treats diseases according to a family-transmitted formula is allowed to prescribe the formula already recognized and approved by the Ministry of Public Health or the health service. He/she is allowed to prepare and product the drugs according to the family-transmitted formula to directly treat his/her patients.

4. Criteria and conditions for opening and area of operation of a service establishment for convalescence and functional rehabilitation by traditional national medicine.

4.1. The applicant for opening a private service establishment for convalescence and functional rehabilitation must, in terms of professional qualification, have acquired the technical level equal to or higher than that of a technician of national medicine and must have at least two years of practice at a lawful establishment of traditional national medicine.

He must have the housing and technical conditions and equipment meeting the requirements of the profession and the area of operation already approved by the Ministry of Public Health.

4.2. Area of operation: A private service establishment for convalescence or functional rehabilitation by traditional national medicine is entitled to use methods of traditional national medicine already approved by the Ministry of Public Health to help its patients who come to the place to exercise according to the prescriptions of the physician (doctor or physician of national medicine or national medicine practitioner).

5. Criteria, conditions for opening and area of operation of a service establishment for medical treatment by acupuncture, massage, point pressure and medical fumigation.

5.1. Criteria and conditions for opening:

The applicant must have the professional qualification of a technician in national medicine recognized by the Ministry of Public Health or the health service and must have at least two years of practice at lawful traditional national medicine establishments.

- He must have housing facilities and technical equipment meeting the requirements of the profession and the area of operation.

5.2. Area of operation: He is entitled to use the methods of acupuncture, massage, point pressure, medical fumigation and other methods of traditional national medicine approved by the Ministry of Public Health and suited to his professional standard to treat his patients according to prescriptions of a physician (doctor or physician of national medicine, or national medicine practitioner).

B. Traditional national pharmacy

1. Criteria and conditions for opening and area of operation of an establishment dealing in raw medicines:

1.1. Criteria and conditions for opening:

- The applicant must be, in terms of professional qualification, recognized by the Ministry of Public Health or the health service as having acquired the necessary knowledge of pharmaceuticals used in traditional national medicine (Point 2, Part I Circular No.5-BYT/TT on the 15th of May, 1993 of the Ministry on the granting of certificate of professional qualifications in traditional national pharmacy) and must have at least two years of practice at lawful traditional national pharmacy establishments.

- He must have a permanent place of operation and the necessary means to preserve the pharmaceutical materials and to conduct his practice.

1.2. Area of operation: Buying and selling pharmaceutical materials to prepare traditional national drugs.

2. Criteria and conditions for opening and are of operation of a dispensary of processed drugs:

2.1. Criteria and conditions:

The applicant must, in terms of professional qualification, have the level of an intermediate pharmacist and higher, must have the certificate of having learnt traditional pharmacy or has been recognized by the Ministry of Public Health or the health service as having acquired a deep knowledge of the properties and effects of traditional national pharmaceutical materials and the way to prepare them (Point 3, Part 1 of Circular No.5-BYT/TT on the 15th of May 1993 of the Ministry of Public Health guiding the granting of certificates of qualification in traditional pharmacy), and must have at least two years of practice at lawful establishments of traditional national medicine and pharmacy.

- He must have a permanent place for his business with the necessary sanitary conditions and the necessary means to display and preserve the medicine.

- He must have a place for preparing drugs and the necessary instruments in accordance with the method of preparation of preparation of traditional national medicine.

2.2. Area of operation: Processing raw pharmaceutical materials into medicine for selling according to the prescriptions of a national medicine practitioner to the treatment establishments of traditional national medicine.

3. Criteria and conditions for opening and area of operation of an establishment dealing in medicine in sticking patches, liquid, balls and powder.

3.1. Criteria and conditions:

- The applicant must, in terms of professional qualification, have a university degree in pharmacy and the certificate of having learnt traditional pharmacy, or a practitioner recognized by the Ministry of Public Health or the health service as having acquired the level of a traditional medicine pharmacist stipulated in Circular No.5-BYT/TT on the 15th of May, 1993 of the Ministry of Public Health guiding the granting of certificates of qualification in traditional pharmacy and must have at least five years of practice at establishments of traditional national medicine and pharmacy.

- An establishment of this type may comprise three sections:

+ Production and preparation.

+ Buying and selling.

+ Quality control of materials and finished products.

- It must have the appropriate technical equipment meeting the requirement of production and the necessary instruments for preservation against insects and mold in order to ensure the quality of the drugs.

- The housing conditions must respond to the requirements of production, the place must be airy and ensure sanitary and other requirements of a place for preparing drugs.

- It must be provided with the necessary fire equipment.

3.2. Area of operation: Producing and trading in finished products of its own in traditional national medicine already approved by the Ministry of Public Health from which it has received a license for production and circulation.

4. Criteria and conditions for opening and area of operation of a dispensary of family transmitted drugs:

4.1. Criteria and conditions:

- The applicant must be recognized by the Ministry of Public Health or the health service as being possessed of a family transmitted recipe, having perfect knowledge of the technique of preparation and use of this recipe (Circular No.5-BYT/TT on the 15th of May, 1993 of the Ministry of Public Health guiding the granting of the certificate of the professional qualifications in traditional pharmacy).

- The place of operation must be airy, have the necessary sanitary conditions and conditions for the preparation of the drugs.

- It must have the appropriate equipment to ensure the quality of the drugs.

4.2. Area of operation: Producing and selling the drugs prescribed in the family-transmitted formula once it has been licensed by the Ministry of Public Health for production and circulation.

5. Criteria and conditions for opening and area of operation of an agent of traditional national medicine.

5.1. Criteria and conditions:

- The applicant must have at least the level of a drug preparator with a certificate of having learnt traditional pharmacy or is certified by the Ministry of Public Health or the health service as having acquired the necessary knowledge of the properties and effect of the drugs of traditional national medicine (finished products) stipulated in Circular No.5-BYT/TT on the 15th of May, 1993, and has at least two years of practice at lawful traditional national medicine production establishments.

- He/she must have a specific address for business and have the necessary means to display and preserve his/her medicine.

5.2. Area of operation: Selling finished products (medicine in sticking patches, liquid, balls or powder) of traditional national medicine already licensed by the Ministry of Public Health for production and circulation.

6. The traditional pharmacy practitioners, pharmacists with a university degree having a certificate of having learnt traditional pharmacy, are entitled to open shops dealing in both decoction and drugs in sticking patches, liquid, balls and powder if they meet the criteria and conditions stipulated in Part II of this Circular.

III. PROCEDURES AND COMPETENCE IN GRANTING CERTIFICATES OF CRITERIA AND CONDITIONS FOR OPENING PRIVATE TRADITIONAL MEDICINE AND PHARMACY ESTABLISHMENTS

1. The file shall comprise:

1.1. An application with specification of location, form and contents (area) of the practice and the duration of operation. If the applicant is a public servant or government employee in active service, he/she must have the written consent of the head of the office where he/she is working.

1.2. A CV with photograph and certified by the People's Committee of the commune or ward where the applicant has permanent residence or by the office where the applicant is working.

1.3. A copy of the professional diploma or a certificate of professional standard issued by the Ministry of Public Health or the health service (with certification by the Notary Public).

1.4. A certificate of the period of practice at lawful traditional national medicine establishments as stipulated in this Circular.

1.5. An inventory of the material bases, houses and workshops professional equipment and investment capital with expertise of the health service.

1.6. The list and certificates of qualification and contract of the collaborators.

1.7. A program of initial activities if it is a private traditional national medicine clinic.

1.8. A certificate of health certified by the district polyclinic.

2. Competence in considering and issuing the certificate of criteria and conditions for opening a private traditional national medicine clinic.

2.1. The Minister of Public Health shall issue the decision to set up a council to consider the criteria and conditions for establishing a private traditional and national medicine clinic. The council shall include a representative of the Central Committee of the Vietnam Traditional Medicine Association.

2.2. Basing himself on the proposal of the council's chairman, the Minister of Public Health shall issue the certificate of criteria and conditions for opening the clinic to the applicant.

2.3. This certificate shall be valid for five years. Three months before its expiry, the applicant shall compile a file and send it to the Ministry of Public Health (the Traditional Medicine Department) for reappraisal.

3. Competence in considering and issuing certificate of criteria and conditions for opening other private traditional national medicine and pharmacy establishments is defined in this Circular:

3.1. The director of the health service in a province or city directly under the Central Government shall issue the decision to set up the Council for examining and approving the criteria and conditions for opening a private traditional national medicine and pharmacy establishment. The Council shall include a representative of the Traditional Medicine Association in the province or city directly under the Central Government who shall take part in examining the professional ethics and qualifications (medical ethics, medical philosophy and medical skill) of the applicant.

3.2. Basing himself on the proposal of the Chairman of the Council, the director of the health service in the province or city directly under the Central Government shall issue to the applicant the certificate of criteria and conditions for opening a traditional medicine and pharmacy establishment in the form already approved by the expertise council.

3.3. This certificate is valid for three years. Three months before its expiry, the owner of the private traditional national medicine and pharmacy establishment must compile a file asking for reappraisal and send it to the health service so that the certificate may be renewed.

The area of operation written in the license must be identical to the one written in the certificate of criteria and conditions for opening the private traditional medicine and pharmacy establishment issued by the Ministry of Public Health or the health service.

IV. PROFESSIONAL REGULATIONS FOR PRACTITIONERS OF MEDICAL EXAMINATIONS AND TREATMENT BY TRADITIONAL NATIONAL MEDICINE

1. The practitioner who gives medical examinations and treatment by traditional national medicine, can use only the means and methods of examination and treatment of traditional national medicine already approved by the Ministry of Public Health (but a doctor of national medicine may combine traditional and modern methods to raise the quality of diagnosis and treatment).

2. The establishments practicing medical examinations, treatment, services or functional rehabilitation by traditional national medicine must keep medical records of patients who come for daily examination and treatment and make periodical reports of its activities to the district or ward medical center as scheduled.

3. The practitioner and establishment must strictly observe the regulations on sterilization and bacteria-killing issued by the Ministry of Public Health in order to avoid contamination and infection in the course of treatment.

A private traditional national medicine clinic must fully observe the regulations and regimes for hospitals issued by the Ministry of Public health.

4. If the condition of a patient does not improve after long period of treatment or if the patient shows complicate developments which go beyond the capability of the clinic, the practitioner or the clinic shall make a resume of the evolution of the disease or sickness and the method of treatment, then direct the patient to continue treatment at a State-run medical establishment.

5. In case the patient dies, the practicing doctor and the owner of the establishment must compile a file with full description of the development and the emergency measures already taken, the cause of the death, the experiences from the case. This file shall be kept at the establishment for five years. The doctor and the owner of the establishment have the responsibility to make a full report to the responsible office whenever it requests.

6. Medical prescriptions must be made in the form issued by the health service, all the items printed in the form must be filled, the hand writing must be clear and the name of the drugs must conform with the names already entered in the Vietnam Materia Medica or the popular names in the locality. At the end of the prescriptions, the medical practitioner must clearly specify the number of mixtures, the way to administer them with signature, full name and address of the physician.

7. If the prescription includes a toxic drug on the A or B list, there must be two copies of the prescription, one to be kept by the physician for at least one year. The name of the toxic drug must be written in block letters and the dose written in full letters with concrete instructions on usage.

8. The scale used in drug selling must be a standardized scale using the gram as unit.

9. The weighing of drugs must be done in strict accordance with the physician's prescription, each drug must be marked after the weighing, then equally divided according to the number of mixtures prescribed.

With regard to toxic drugs in the A or B list, they must be weighed for each mixture and entered into two identical receipts. In the receipts there must be written the way of administering these toxic drugs as prescribed by the physician. A copy of the receipt shall be given to the patient and the physician shall keep the other copy for at least one year.

10. The drugs must be preserved in compartmentalized cabinets, in boxes or bottles with the names of the drugs stuck outside. Toxic drugs (in the A and B lists) must be preserved in strict accordance with the regulation of the Ministry of Public Health on toxic drugs. It is forbidden to sell fake drugs or any other drugs the quality of which is not guaranteed. Itinerant sale of drugs (usually accompanied with demonstration of martial arts) is strictly forbidden.

V. PROFESSIONAL REGULATIONS FOR THE PRIVATE ESTABLISHMENTS PRODUCING TRADITIONAL NATIONAL MEDICINE

1. Production establishments:

1.1. The instruments and equipment used in the production of medicine must be suitable for each kind of medicine. They must not be used also as household utensils in order not to affect the quality of medicine.

1.2. In the processing of raw materials into finished medicines, the method of processing traditional national medicine must be strictly observed. In the manufacture of medicine in the form of sticking patches, liquid, balls or powder there must be strict observance of the regulations of the Ministry of Public Health if it is used for direct treatment of the patients, and in strict observance of the manufacturing process already approved by the Ministry of Public Health in the file of application for the production and circulation of drugs, if it is used for circulation on the market.

1.3. In the process of production there must be strict observance of the regime of control and observation at all stages: weighing, measuring, counting, packing.

1.4. Before they are taken out of the workshop, the products must be tested qualitatively. It is allowed to market only the products which meet the quality norms already approved by the Ministry of Public Health in the file of application for production and circulation of drugs.

1.5. The label, package, contents, preservation and utilization term must be fully recorded and fully implemented as has been approved by the Ministry of Public Health in the file of application for production and circulation of drugs.

1.6. There must be records to monitor the production, quality and sale of medicine.

a/ A ledger on the intake and delivery of raw materials.

b/ A ledger recording the manufacturing process.

c/ A ledger to monitor the quality of products.

d/ A ledger on the control of the quality of the raw materials and finished products.

e/ A ledger to record purchases and sales.

2. With regard to a private dealing in traditional national medicine:

2.1. They are allowed to deal in pharmaceutical materials and products of traditional national medicine already licensed by the Ministry of Public Health for production and circulation and must guarantee the quality already approved.

2.2. There must be a record of daily purchases and sales.

VI. FINAL PROVISIONS

1. This Circular takes effect on the date of signing and shall apply to all persons practicing traditional national medicine and pharmacy. All earlier regulations contrary to this Circular are now annulled.

2. The health service in the provinces and cities directly under the Central Government have the responsibility to organize the study and implementation of this Circular. They must have a section to monitor, control and sum up the situation and make periodical reports on the results of the implementation to the Ministry of Public Health (Traditional Medicine Department).

In the process of implementation, if any difficulty arises, it should be reported in writing to the Ministry (Traditional Medicine Department) for settlement.

For the Minister of Public Health

Vice Minister

Professor LE VAN TRUYEN